FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
K Number: K980999
·
Decision Nov 6, 1998
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
28
Review Days
233
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Basic Information
- Device Name
- ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT
- K Number
- K980999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Instrument Makar, Inc.
- Date Received
- March 18, 1998
- Decision Date
- November 6, 1998
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K955835 | FLUID BARRIER BOOT KNEE & ANKLE-HIGH | Nov 19, 1996 | Substantially Equivalent |
| K960555 | BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR | Jul 9, 1996 | Substantially Equivalent |
| K943249 | BIOABSORBABLE INTERFERENCE SCREW | Jul 31, 1995 | Substantially Equivalent |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Feb 23, 1995 | Substantially Equivalent |
| K944062 | LAPRASCOPIC GRASPER | Feb 23, 1995 | Substantially Equivalent |
| K930980 | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW | Feb 10, 1994 | Substantially Equivalent for Some Indications |
| K923841 | BONE SCREWS | Oct 27, 1993 | Substantially Equivalent |